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FDA 510(k)

Sterile Latex Surgical Gloves Powder Free

K-Number: K211478 · 2021-09-16

ApplicantAspen Glove Sdn. Bhd.
Decision Date2021-09-16
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Latex Surgical Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-09-16 under 510(k) number K211478. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Latex Surgical Gloves Powder Free?

Sterile Latex Surgical Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Aspen Glove Sdn. Bhd.. The 510(k) number is K211478.

When did Sterile Latex Surgical Gloves Powder Free receive FDA 510(k) clearance?

Sterile Latex Surgical Gloves Powder Free received FDA 510(k) clearance on 2021-09-16, under 510(k) number K211478.

Who is the listed applicant for Sterile Latex Surgical Gloves Powder Free?

The FDA 510(k) record lists Aspen Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Latex Surgical Gloves Powder Free?

The FDA product code for Sterile Latex Surgical Gloves Powder Free is KGO.

Other records listing Aspen Glove Sdn. Bhd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213076AspenMed+K211477Latex Examination Powder Free GlovesK211479Blue Nitrile Examination Glove Powder Free

Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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